Cell SALVage in Obstetrics

Conditions

Haemorrhage / Caesarean Section (CS) Pregnancy and Childbirth Labour and delivery complicated by intrapartum haemorrhage, not elsewhere classified

Carol McLoughlin, Tracy Roberts, Louise Jackson, Philip Moore, Matthew Wilson et al. (20 authors)

BMJ Open2019-02-0117 citations

10.1136/bmjopen-2018-022352

A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial.

Khan KS, Moore P, Wilson M, Hooper R, Allard S, Wrench I, Roberts T, McLoughlin C, Beresford L, Geoghegan J, Daniels J, Catling S, Clark VA, Ayuk P, Robson S, Gao-Smith F, Hogg M, Jackson L, Lanz D, Dodds J.

2018-01-0133 citations

10.3310/hta22020

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)

Khalid S. Khan, Philip Moore, Matthew Wilson, Richard Hooper, Shubha Allard et al. (20 authors)

PLoS Medicine2017-12-1969 citations

10.1371/journal.pmed.1002471

Interventions

Intra-operative Cell Salvage (IOCS): A technique which allows the blood lost during surgery to be returned to the patient. Blood is aspirated from the surgical field

the red cell component isolated by centrifugation and after washing and filtration, re-transfused. The ability to return salvaged blood is dependent on sufficient volume being collected and processed.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. 16 years of age or older 2. Delivery by elective or emergency caesarean section with an identifiable increased risk of haemorrhage 3. Ability to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Elective first Caesarean section for maternal request or breech presentation 2. Sickle cell disease 3. Active malignancy contraindicated to CS e.g. abdominal cancer 4. Cultural or social beliefs contraindicating blood transfusion e.g. Jehovah's Witnesses 5. Significant antibodies making it difficult to find cross matched blood for transfusion 6. Unable to understand written and spoken English

Design outcomes

Primary

Measure	Time frame
The proportion of women needing peripartum transfusion. For the IOCS group this is measured by the use of donor blood transfusion; transfusion of routinely salvaged blood as part of the intervention will not count as an event. For the standard care group this is measured by the use of donor blood transfusion and/or the use of salvaged blood transfusion set up as an emergency to deal with haemorrhage.	—

Measure

Time frame

The proportion of women needing peripartum transfusion. For the IOCS group this is measured by the use of donor blood transfusion; transfusion of routinely salvaged blood as part of the intervention will not count as an event. For the standard care group this is measured by the use of donor blood transfusion and/or the use of salvaged blood transfusion set up as an emergency to deal with haemorrhage.

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Secondary

Measure	Time frame
1. Severity of events quantified as the volume of blood transfused, where transfusion is defined as above for the primary outcome - i.e. donor blood transfusion in the IOCS group, and donor blood transfusion plus salvaged blood transfusion set up as an emergency in the standard care group 2. Time to first mobilisation after CS 3. Length of hospital stay 4. Multidimensional Fatigue Inventory (MFI) 5. Resources used intra- and post-operatively, including IOCS consumables and donor blood transfusions 6. Costs of staff training, service procurement and provision of care will be collected alongside clinical outcomes 7. Safety Outcomes: 7.1. Pre- and post-operative serum haemoglobin, and mean fall in haemoglobin level 7.2. Maternal exposure to fetal blood measured by Kleihauer test 7.3. Requirement for and the dose of anti-D antibody administered 8. Process outcomes 8.1. The number of cases in the IOCS arm where sufficient blood is harvested for re-transfusion 8.2. Volume of blood returned in IOCS (mean/SD) 8.3. Proportion of transfusion reaction associated with allogeneic donor blood transfusion 8.4. Episodes of technical failure of IOCS	—

Measure

Time frame

1. Severity of events quantified as the volume of blood transfused, where transfusion is defined as above for the primary outcome - i.e. donor blood transfusion in the IOCS group, and donor blood transfusion plus salvaged blood transfusion set up as an emergency in the standard care group 2. Time to first mobilisation after CS 3. Length of hospital stay 4. Multidimensional Fatigue Inventory (MFI) 5. Resources used intra- and post-operatively, including IOCS consumables and donor blood transfusions 6. Costs of staff training, service procurement and provision of care will be collected alongside clinical outcomes 7. Safety Outcomes: 7.1. Pre- and post-operative serum haemoglobin, and mean fall in haemoglobin level 7.2. Maternal exposure to fetal blood measured by Kleihauer test 7.3. Requirement for and the dose of anti-D antibody administered 8. Process outcomes 8.1. The number of cases in the IOCS arm where sufficient blood is harvested for re-transfusion 8.2. Volume of blood returned in IOCS (mean/SD) 8.3. Proportion of transfusion reaction associated with allogeneic donor blood transfusion 8.4. Episodes of technical failure of IOCS

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Countries

United Kingdom

Outcome results

None listed